ixabepilone in treating patients with relapsed and/or refractory stage iii or stage iv ovarian epithelial or primary peritoneal cancer

Conditions: Ovarian Cancer; Peritoneal Cavity Cancer

Summary: rationale: drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of ixabepilone in treating patients who have relapsed and/or refractory stage iii or stage iv ovarian epithelial cancer or primary peritoneal cancer.

objectives: primary * determine the antitumor activity of ixabepilone, in terms of clinical response and progression-free survival, in patients with relapsed and/or refractory stage iii or iv ovarian epithelial or primary peritoneal cancer. * determine the nature and degree of toxicity of this drug in these patients. secondary * correlate pre-ixabepilone survivin mrna and protein levels in patient-derived ovarian cancer cells with quality of response (i.e., at least partial response vs no response). * correlate cyp3a4 (3a4\*1b), 3a5 (3a5\*1), and 3a7 (er6 p variation) allelic polymorphisms with parent drug kinetic parameters, toxicity, and efficacy of this drug in these patients. outline: this is a multicenter study. patients receive ixabepilone iv over 1 hour once weekly on weeks 1-3. treatment repeats every 4 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 12-37 patients will be accrued for this study within 12 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed stage iii or iv ovarian epithelial cancer or primary peritoneal carcinoma * recurrent or refractory disease * previously treated with 1, and only 1, prior chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound and paclitaxel or docetaxel * initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment * bidimensionally measurable disease by physical exam, ct scan, or mri * ascites and pleural effusions are not measurable disease * no prior irradiation to indicator lesions patient characteristics: age * 18 to 75 performance status * gog 0-2 life expectancy * not specified hematopoietic * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * no prior bleeding disorder or unexplained bleeding hepatic * bilirubin no greater than 1.5 times upper limit of normal (uln) * sgot/sgpt no greater than 2.5 times uln * alkaline phosphatase no greater than 2.5 times uln renal * creatinine no greater than 1.5 times uln other * no active infection requiring antibiotics * no grade 2 or greater neuropathy (sensory and motor) * no other malignancy within the past 5 years except nonmelanoma skin cancer * no prior recurrent grade 2 or greater hypersensitivity reactions to cremophor el, docetaxel, or paclitaxel * no other medical condition that would preclude study participation * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy * at least 3 weeks since prior biologic or immunologic therapy for ovarian epithelial or primary peritoneal carcinoma chemotherapy * see disease characteristics * at least 3 weeks since prior chemotherapy and recovered * no prior ixabepilone * no prior cytotoxic chemotherapy (including retreatment with initial chemotherapy regimens) for recurrent or persistent ovarian epithelial or primary peritoneal carcinoma endocrine therapy * at least 1 week since prior hormonal therapy for ovarian epithelial or primary peritoneal carcinoma * concurrent hormonal replacement therapy allowed radiotherapy * see disease characteristics * at least 3 weeks since prior radiotherapy and recovered * no prior radiotherapy to a site of measurable disease used on study * no prior radiotherapy to more than 25% of bone marrow surgery * see disease characteristics * recovered from prior surgery other * at least 3 weeks since other prior therapies for ovarian epithelial or primary peritoneal carcinoma * no prior cancer treatment for other invasive malignancies that would preclude study participation * no concurrent heparin or other anticoagulants * no concurrent hypericum perforatum (st. john's wort) or any product containing this compound

Keywords: stage iii ovarian epithelial cancer stage iv ovarian epithelial cancer recurrent ovarian epithelial cancer peritoneal cavity cancer